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Evaluation of the time dependent variability of the anti-factor Xa activity of therapeutic nadroparin in critically ill patients: a pharmacokinetic study

Evaluation of the time dependent variability of the anti-factor Xa activity of therapeutic nadroparin in critically ill patients: a pharmacokinetic study - VARIAXA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48502
Enrollment
18
Registered
2020-02-13
Start date
2020-08-24
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Farmacokinetiek van therapeutisch gedoseerd Nadroparine pharmacokinetics nadroparin

Interventions

None listed

Sponsors

Martini Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) Admitted to the Intensive Care with nadroparin in therapeutic dose (1-daily or 2-daily) (2) Age * 18 years

Exclusion criteria

Exclusion criteria: (1) Pregnancy (2) Requiring hemodialysis (HD) or Continuous Veno-Venous Hemofiltration (CVVH) (3) Treated with a DOAC, unfractionated heparin, another LMWH, a GP IIb / IIIa receptor antagonist 96 hours to 0 hours before the first bloodsample is drawn or during bloodsampling. (4) Participation in another study

Design outcomes

Primary

MeasureTime frame
{[Cmax at tmax] minus [minimal measured anti-Xa between T3h to 5h] / [Cmax at tmax] } · 100%

Secondary

MeasureTime frame
To evaluate the pharmacokinetics of therapeutic nadroparin in a general intensive care unit population by measuring anti-factor Xa levels.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)